ICH Stability program to support semipermeable conditions Regulatory team supports project throughout regulatory lifecycle All documentation provided in eCTD format
Dedicated team of chemists to support all aspects of development from method development, method validation, sterility & bioburden along with our robust microbiology lab.
Development engineering teams lead all aspects of product development/transfers from the clinical study stage and manage projects throughout the development lifecycle, process validation & commercial launch.
TRC registers with FDA as a 503B Outsourcing and Repackaging Facility
Plant expansion of over 150,000 sq ft for packaging and distribution
TRC acquired by Humanwell Health Group
TRC obtains fourth ANDA for Levalbuterol Capacity of 1.7 Billion units 10 BFS machines 4 fully automatic packaging lines 1 semi-automatic packing line
EU compliant expansion Quality & Development Lab expansion
TRC obtains third ANDA for IpratropriumAlbuterol
Olympus Partners acquires Holopack International and forms The Ritedose Corporation